Shares of Radius Health, Inc. (RDUS - Free Report) rallied almost 6% after the company announced its preliminary results for the full year 2018. However, shares of Radius declined 49.8% in the past year compared with the industry’s decline of 15%.
The company announced that it exceeded its 2018 financial guidance, with full-year U.S. net sales of lead drug Tymlos surpassing the upper range of $95-$98 million. We remind investors that the FDA approved Tymlos (abaloparatide-SC) for the treatment of postmenopausal women with high risk osteoporosis for fracture in April 2017. Tymlos is currently the only promoted anabolic drug in the U.S. market that is consistently increasing its prescriber base.
In 2018, Tymlos captured on average 20% of the U.S. anabolic osteoporosis market and exited the year with a 27% total U.S. anabolic market share. In December, market share of new anabolic patients was 40%. The company expects to become the U.S. anabolic market leader in 2019. Radius also plans to advance its late-stage clinical pipeline of two innovative phase III products, elacestrant and abaloparatide-patch, both with blockbuster potential.
The company initiated a phase III EMERALD study for elacestrant in December 2018. It is the first phase III study to prospectively evaluate the treatment benefit for second and third-line breast cancer patients following cyclin-dependent kinase (CDK) 4/6 inhibitor therapy as well as prospectively compare outcomes in patients whose tumors harbor estrogen receptor 1 gene (ESR1) mutations.
The company is developing an abaloparatide transdermal patch (abaloparatide-patch) for potential use in the treatment of postmenopausal women with osteoporosis. In January 2018, Radius met with the FDA to discuss the regulatory development path for the abaloparatide patch. The FDA agreed that, depending on the study results, a single, randomized, open label, active-controlled, non-inferiority (to abaloparatide-SC) study involving up to 500 patients with postmenopausal osteoporosis at high risk of fracture would be sufficient to gain approval for the abaloparatide patch.
The company reiterated its 2019 financial guidance and expects full-year Tymlos U.S. net sales to be between $155 million and $175 million, and its year-end cash, cash equivalents and investments balance to exceed $100 million.
Zacks Rank & Stocks to Consider
Radius currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth considering are Adaptimmune Therapeutics plc. (ADAP - Free Report) , Axovant Sciences Ltd. (AXON - Free Report) and Editas Medicine, Inc. (EDIT - Free Report) . While Adaptimmune and Axovant sport a Zacks Rank #1 (Strong Buy), Editas carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Adaptimmune’s loss per share estimates have narrowed from 94 cents to 93 cents for 2018 and from $1.23 to $1.22 for 2019 in the past 60 days.The company delivered a positive earnings surprise in one of the trailing four quarters, with average of 44.81%.
Axovant’s loss per share estimates have narrowed from $1.68 to $1.25 for 2019 and from $1.34 to $1.03 for 2020 in the past 60 days.
Editas’ loss per share estimates have narrowed from $3.00 to $2.18 for 2018 and from $3.36 to $2.84 for 2019 in the past 90 days.The company delivered a positive earnings surprise in two of the trailing four quarters, with average of 10.85%.
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